Clinical Trial Master System 2018

CLINICAL TRIAL MASTER SYSTEM 2018

PROJECT CHARTER

Version 1.0

04/21/2018

VERSION HISTORY

TABLE OF CONTENTS

1        INTRODUCTION        5

1.1        Purpose of Project Charter        5

2        PROJECT AND PRODUCT OVERVIEW        5

3        JUSTIFICATION        5

3.1        Business Need        5

3.2        Public Health and Business Impact        5

4        SCOPE        6

4.1        Objectives        6

4.2        Major Deliverables        6

4.3        Boundaries        6

5        DURATION        7

5.1        Timeline        7

5.2        Executive Milestones        7

6        BUDGET ESTIMATE        7

6.1        Funding Source        7

6.2        Estimate        7

7        ASSUMPTIONS, CONSTRAINTS AND RISKS        8

7.1        Assumptions        8

7.2        Constraints        8

7.3        Risks        8

8        PROJECT CHARTER APPROVAL        11

1. INTRODUCTION

1. PURPOSE OF PROJECT CHARTER

The Clinical Trials Master System 2018 project charter documents and tracks the necessary information required by decision maker(s) to approve the project for funding. The project charter should include the needs, scope, justification, and resource commitment as well as the project’s sponsor(s) decision to proceed or not to proceed with the project.  It is created during the Initiating Phase of the project.

The intended audience of the Clinical Trials Master System 2018 project charter is the senior leadership team.

1. PROJECT AND PRODUCT OVERVIEW

The Clinical Trials Master System 2018 will be revamp the current CTMS from being a specimen driven set up, to a visit orientated set up, where we will better be able to manage client expectations while also adding new services that the client may choose from, including the addition of the client portal and app for mobile devices. New services to be offered and included in the CTMS are storage only study and data only study options. The newly implemented CTMS would replace the current system entirely on a gradual period of time, with all new studies being set up in the new system upon its completion, while existing studies will be phased in over a period of 12 to 24 months. The project is expected to be completed in 12 months, at a cost of $20,000,000. 

1. JUSTIFICATION

1. BUSINESS NEED

A revamped CTMS is necessary for our organization to remain competitive in the industry and expand our offerings to current and future clients. The new system will also provide our project management team far more flexibility in customization for client needs while not adding to time and cost for the study implementation. A high degree of automation will be built into the system so that the system may handle a heavier load so that current resources can handle more clients and projects at one given time.

1. PUBLIC HEALTH AND BUSINESS IMPACT

Upon completion, the system will reduce current costs while handling a heavy workload of studies, which will increase revenue. As well as add the ability of expanding offerings to current and future clients once the system is complete, as well as enable our organization to add “segments” to the CTMS to continue expanding our client offerings at little to no cost.

1. SCOPE

1. OBJECTIVES

Improving our current systems while removing limitations on services that can be offered to clients at a reduced cost, while increasing revenue from an expanded services menu.

The objectives of the Clinical Trials Master System 2018 are as follows:

• Expand client services menu for clinical trial studies
• Reduce current costs
• Increase annual revenues from new service offerings

1. MAJOR DELIVERABLES

The following table presents the major deliverables that the project’s product, service or result must meet in order for the project objectives to be satisfied.

1. BOUNDARIES

The Clinical Trials Master System 2018 project will exclude existing Anatomic Pathology and Genomics testing services as those are housed in LabVantage, a Company A Legacy system that is client specific. The revamped CTMS will include its own version of A&P and Genomics testing and storage services that can be offered to any client interested in the services.

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